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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K912447
Device Name SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
Applicant
Medical Laser, Inc.
2605 Fernbrook Ln.
Minneapolis,  MN  55447
Applicant Contact GREGORY J MATHISON
Correspondent
Medical Laser, Inc.
2605 Fernbrook Ln.
Minneapolis,  MN  55447
Correspondent Contact GREGORY J MATHISON
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Code
GCT  
Date Received06/03/1991
Decision Date 09/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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